Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.

Claudia Teresa Tovar Palacio

Status: Enrolling

Conditions: Overweight and/or Obesity; Preventing Malnutrition; Children - Malnutrition

Treatments: Other: Control; Device: School B

Study type: Interventional

Funder types: Other

Identifiers

NCT07159971

3738

Details and patient eligibility

About

This proposal aims to enhance the well being of schoolchildren and their families through a mobile application and multidisciplinary intervention model grounded in authoritative parenting principles and social cognitive theory.

Full description

Childhood is recognized as a critical period of metabolic sensitivity, during which excess adiposity increases the likelihood of developing metabolic abnormalities in adulthood by approximately 70%, including hypertension, dyslipidemia, insulin resistance, hyperuricemia, and non-alcoholic fatty liver disease. In Mexico, overweight and obesity affect 35.5% of school-aged children, inevitably contributing to the growing prevalence of non-communicable chronic diseases. Data from ENSANUT 2018 place Sonora among the five states with the highest rates of obesity, with 22.2% of adolescents aged 12-19 years classified as obese. This epidemiological context highlights the pressing need for innovative strategies to promote prevention and early risk detection during childhood.

Evidence indicates that mobile health (mHealth) applications may effectively reduce body weight and prevent fat accumulation. Nevertheless, only a limited number of studies have applied mHealth interventions to prevent pediatric adiposity or to foster behavioral changes in comparison with conventional nutritional approaches. The proposed model incorporates a communication strategy designed to monitor participant needs, offer engagement incentives, and promote adherence to the study protocol.

The primary research question addresses whether a family-focused intervention can effectively improve eating patterns and food-related behaviors among students enrolled at "La Caridad" Educational Center in Nacozari de García, Sonora.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Families of children between 5 and 9 years old.
• Children without any medical or nutritional treatment for obesity.
• Children classified as normal weight, overweight, or obese based on WHO (Z-score: height for age and BMI for age).
• Offspring of mothers aged between 18 and 45 years at delivery.
• Term infants from normoevolutive pregnancies without maternal comorbidities.
• Families who have a cell phone with internet access and an installed camera.

Exclusion criteria

• Children who are currently suffering from a pathology that requires medication or special treatment
• Mothers/Fathers/Guardians who are currently suffering from a pathology that requires medication or special treatment.
• Children who have a physical/mental impairment to perform physical activities.
• Children from surrogate mothers who have presented at least 2 of the 11 DSM-5 criteria for substance use disorder (alcohol, tobacco, cannabis, or other illegal drugs) before or during the participating child's gestation.
• Children from multiple pregnancies.
• Parents who do not own a smartphone compatible with the app will be excluded from this study (i.e., version 5.0 or higher for Android).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

School B

Experimental group

Description:

Nutritional therapy supported by a mobile application. The app integrates a multimodal approach (educational content, interactive tools, and gamification) to promote healthy eating, featuring parent-child dyad-focused resources such as recipe tutorials with family-specific adaptations.

Treatment:

Device: School B

School A.

Active Comparator group

Description:

Nutritional therapy will be delivered through a mobile application that will integrate a multimodal approach, including educational content, interactive tools, and gamification, to promote healthy eating. The application will incorporate parent-child dyad-focused resources, such as recipe tutorials adapted to specific family needs.

Treatment:

Other: Control